The Realtime Detection for Individual Variation of Analgesic ：A Comparison of Sufentanil vs Fentanyl

This study is currently recruiting participants.

Verified December 2012 by Huazhong University of Science and Technology

Sponsor:

Information provided by (Responsible Party):

Zhang Xianwei, Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT01748071

First received: December 9, 2012

Last updated: December 10, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 9, 2012

Last Updated Date

December 10, 2012

Start Date ^ICMJE

June 2012

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Rangeability of pressure pain threshold [ Time Frame: 5 month ] [ Designated as safety issue: Yes ]
According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics
Rangeability of Nacro-trend index [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
According to the measurement of Nacro-trend index before and after intravenous injection of opioid analgesics

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01748071 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rangeability of Ramsay Sedation Scale [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
According to the investigation of Ramsay Sedation Scale before and after intravenous injection of opioid analgesics
Rangeability of mean arterial pressure [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics
Rangeability of heart rate [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
According to the measurement of heart rate before and after intravenous injection of opioid analgesics
Rangeability of respiratory frequency [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
According to the measurement of respiratory frequency before and after intravenous injection of opioid analgesics

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Realtime Detection for Individual Variation of Analgesic ：A Comparison of Sufentanil vs Fentanyl

Official Title ^ICMJE

Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics

Brief Summary

Purpose: This study aimed to find a quick and timely way to investigate the individual variation of efficacy of opioid analgesic in Chinese patients undergoing elective surgeries. Methods: 120 female patients receiving elective surgery under general anesthesia were recruited into this study. At the time of routine intravenous anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect, effects on Nacro-trend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system.

Detailed Description

Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

120 Chinese female patients receiving elective surgery under general anesthesia

Condition ^ICMJE

Surgery
Individuality

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Sufentanil group
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
Fentanyl group
Grouped by intravenous injection of fentanyl at the time of anesthesia induction
Saline group
Grouped by intravenous injection of saline before the time of anesthesia induction

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

January 2013

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Aged 20-65 years
Anesthesiologists (ASA) physical status I or II;
Within ±20% of ideal body weight;
Agreed to participate the research

Exclusion Criteria:

History of chronic pain;
Psychiatric diseases;
Diabetes mellitus;
Severe cardiovascular diseases;
Kidney or liver diseases;
Alcohol or drug abuse (according to the criteria of DSM-IV);
Pregnancy or at lactation period;
Disagree to participate to the research

Gender

Female

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Zhang Xianwei, MD

13037154560

znpain@sina.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01748071

Other Study ID Numbers ^ICMJE

Individual Variation

Has Data Monitoring Committee

Yes

Responsible Party

Zhang Xianwei, Huazhong University of Science and Technology

Study Sponsor ^ICMJE

Huazhong University of Science and Technology

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Zhang Xianwei, MD

Huazhong University of Science and Technology

Information Provided By

Huazhong University of Science and Technology

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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